Biological fluid sampling apparatus, assembly and method

ABSTRACT

A sampling apparatus is disclosed that includes a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving fluid into the chamber and a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/364,314, filed Mar. 14, 2002, and is also acontinuation-in-part of U.S. application Ser. No. 09/492,060, filed Jan.27, 2000 now U.S. Pat. No. 6,520,948, which is a continuation-in-part ofU.S. application Ser. No. 09/364,628, filed Jul. 29, 1999 now U.S. Pat.No. 6,387,086, and incorporates by reference each of theabove-identified applications.

The present invention relates to sampling apparatus suitable forcollecting or taking samples of biological fluid, such as blood or bloodcomponents, from fluid circuit assemblies employed in the collection,separation, storage or processing of biological fluids.

BACKGROUND OF THE INVENTION

Disposable fluid circuit assemblies are typically used for collecting,storing, separating and/or other processing of biological fluids, suchas blood from a donor, patient or other source. They are commonlypreassembled, presterilized and fully disposable for safety andconvenience. These assemblies may include plastic tubing, containers,valves, flow control modules and the like for controlling fluid flowthrough the assembly. When employed on the collection or processing ofblood and blood components, these assemblies typically include avenipuncture needle for insertion into the arm of a donor or patient.The needle is usually attached to one end of a flexible plastic tubewhich provides a flow path for the blood to the rest of the fluidcircuit assembly. The other end of the plastic tube may be attached,either directly or indirectly, to one or more plastic bags or containersfor collecting the withdrawn blood or a component of blood, such asconcentrated red cells or platelets, or plasma. Such fluid circuitassemblies may be employed in manual blood collection procedures, wherewhole blood is collected from a donor for later off-site processing, orin automated procedures, where the fluid circuit is mounted on areusable device, such as a centrifuge or other separator, thatautomatically controls flow of blood or components through the assembly.When used for blood collection, these fluid circuit assemblies arecommonly called blood sets or apheresis sets.

The fluid circuit assembly may also include a sampling sub-unit toprovide for collection of a sample of blood or blood component, whichcan be used for testing. It is known to use pierceable junctions in thefluid circuit to allow the user to extract a sample at the desiredlocation. This has associated with it, however, a risk of accidentalneedle puncture as well as undesirable pooling of the fluid at thelocation of the sample port.

As shown in U.S. Pat. No. 5,496,301, it is also known to use a samplebag or pouch that is connected by a length of tubing to a sample tubeholder for cooperating with vacuum sample tube, such as the Vacutainer™sample collection tube marketed by Becton-Dickinson Co. of FranklinLake, N.J. The holder includes a cylindrical shield and an internalneedle within an elastomeric sheath for cooperation with the Vacutainer™tube.

The arrangement illustrated in the above patent, however, is not asconductive to ease of manufacture or economy of packaging as may bedesired. Also, in addition to other apparent shortcomings, it requiresmanual manipulation, such as inversion and the like to retrieve a sampleand may not allow for easy and rapid withdrawal of the entire samplecontained in the sample bag.

SUMMARY OF THE INVENTION

The present invention, is embodied, in one aspect, in a combinationsampling container and a sample device receiver are provided. Inaccordance with this aspect of the present invention, the samplecontainer includes at least one wall defining an interior fluid chamberand a fluid inlet for receiving fluid into the chamber. The sampledevice receiver in this combination is carried by the container wall andis in fluid communication with the chamber to permit withdrawal ofsamples therefrom.

In accordance with a further aspect, the present invention is embodiedin a flexible sample container itself. In this regard, the flexiblecontainer of the invention includes an interior chamber defined by apair of flexible facing plastic sheets that are peripherally sealedtogether, and an inlet tube is attached to the container incommunication with the chamber. The container is adapted for hold in aselected, preferably vertical position and has an imaginary verticalaxis when in that position. The inlet tube extends through theperipheral edge of the container at an acute angle to the vertical axisto compliment holding the container in a vertical disposition.

In yet another aspect of the present invention, the sample container isa pouch comprising a pair of flexible facing sheets peripherally sealedtogether along a peripheral edge to define an interior chamber and isadapted for holding in a vertical disposition. A blood component inlettube communicates with the chamber, and the peripheral edge is inclinedto direct fluid in the chamber to a lowermost region of the chamber, anda fluid sample exit opening is located in one of the sheets in thelowermost region.

The various aspects of the present invention may have stand-aloneapplication, but also are of particular use as part of a biologicalfluid circuit assembly used for processing, storing, treating orseparating a biological fluid in general and blood or blood componentsin particular. In accordance with this aspect, the present invention isgenerally embodied in a disposable closed fluid circuit assembly whichincludes an inlet for receiving a biological fluid into the fluidcircuit assembly, and one or more flow paths for conducting thebiological fluid or components thereof between selected locations withinthe fluid circuit. A sample container or pouch as summarized above,either alone or in combination with a sample device receiver, may beused in combination with the fluid circuit assembly to enhance productmanufacturing and/or packaging, sample collecting and/or taking, and/oruser safety.

In yet another aspect, a method for taking a sample of biological fluidis disclosed. The method includes providing a sampling apparatus. Thesampling apparatus includes a sample container including at least onewall defining a fluid-receiving interior chamber and a fluid inlet forreceiving fluid into the chamber. The sampling apparatus also includes asample device receiver carried by the container wall is in fluidcommunication with the chamber, the receiver being adapted to receive asampling device for withdrawing a fluid sample from the chamber whereinthe sample receiver further comprises a tubular member with a proximalend and a distal end and a cover removably covering the proximal end andwherein the method includes opening the cover. The method furtherincludes holding the sample device receiver and sample containers suchthat the receiver is disposed to receive the sample device intooperative position for sample withdrawal in a generally verticaldirection. The sample device is inserted into the receiver in agenerally vertically downward direction, the sample receivercommunicating with a lowermost region of the sample container as held soas to withdraw a sample generally vertically into the sample device. Themethod further comprises withdrawing the sample device after a sample iswithdrawn and closing the cover over the proximal end.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a plan view of a biological fluid circuit assembly in the formof disposable blood collection or processing set including a samplingapparatus employed in the present invention.

FIG. 2 is a top view of the receiver or holder assembly of FIG. 1 withthe cover in an open position.

FIG. 2A is a top view of a sample tube receiver or holder with amodified cover design.

FIG. 3 is a side view of the receiver assembly of FIG. 2 with the coverin an open position.

FIG. 3A is an enlarged side view of the hinge arrangement of thereceiver in FIGS. 2 and 2A.

FIG. 4 is a perspective view of the receiver assembly of FIG. 2 with thecover in the open position.

FIG. 5 is a partial side view of the receiver assembly with a portion ofthe outer sidewall broken away to show the holder assembly interior incross-section.

FIG. 5A is a side cross-sectional view of a sample tube receiver in thepresent invention, without the needle assembly.

FIG. 5B is a side cross-sectional view of the sample tube receiver ofFIG. 5A with a needle assembly, partially removed, in place.

FIG. 6 is a plan view of a manual fluid circuit assembly embodyingsampling apparatus of the present invention.

FIG. 7 is a plan view of sampling apparatus of the present inventionshown in FIG. 6, including a container and a sample tube receiver.

FIG. 8 is a plan view of an alternative embodiment of sampling apparatusof the present invention.

FIG. 9 is a plan view of a further alternative sampling apparatus of thepresent invention.

FIG. 10 is a plan view of a still further alternative sampling apparatusof the present invention.

FIG. 11 is a vertical cross-section view of sampling apparatus takenalong line 11-11 of FIG. 7 and illustrating the sampling apparatuswithin an outer package.

FIG. 11A is a plan view of the sampling apparatus of 7, showing theinlet tubing coiled around the container and receiver to provide aconvenient and low profile packaging arrangement.

FIG. 12 is a plan view of the sampling apparatus of FIG. 7 with thereceiver cover in the open position to receive a sample tube.

FIG. 13 is a plan view of showing insertion of a sample tube, such as aVacutainer™ vacuum sample tube, into the receiver of FIG. 12.

FIG. 14 is a perspective view of a fluid circuit assembly mounted on areusable device for automated blood processing, and embodying thepresent invention.

FIGS. 15-16 are cross-sectional and top views, respectively, of thepiercing end of a prior art needle.

FIGS. 17-19 are side, top and bottom views, respectively, of thepiercing end of another prior art needle.

FIG. 20 is a side view of a piercing needle particularly useful in thesampling apparatus of the present invention.

FIG. 21 is a top view of the needle of FIG. 20.

FIG. 22 is a bottom view of the needle of FIG. 20.

FIG. 23 is perspective view of the needle of FIG. 20.

FIG. 24 is a perspective view of another needle that may haveapplication in the sampling apparatus of the present invention.

FIG. 25 illustrates the surface of a pierceable septum after repeatedpiercing by a prior art needle.

FIG. 26 illustrates the surface of a pierceable septum after repeatedpiercing by the needle of FIGS. 20-23.

DETAILED DESCRIPTION OF THE DRAWINGS

Turning first to FIGS. 1-5, there is shown, among other things, a holderor receiver (holder and receiver are used interchangeably herein)assembly 40 employed in the present invention. The holder assembly 40may be part of a pre-sterilized fluid circuit assembly such as a bloodcollector and processing set 10 for the manual collection of blood froma donor 11, shown in FIG. 1. Alternatively, holder assembly 40 may bepart of an apheresis processing set for the automated collection ofblood and blood components as illustrated in FIG. 14.

It will also be appreciated that the holder assembly of the presentinvention may be provided as a “stand-alone” device (i.e., not used witha processing set of the type shown or described above) for “direct”withdrawal of blood from a donor or patient. An example of what is meantby a “stand-alone” device is described in U.S. Pat. No. 5,372,143, whichis incorporated herein by reference. Another embodiment of a“stand-alone” receiver of the present invention includes a“double-needled” holder assembly where one of the needles is directlyinserted into the vein of a donor or patient. For purposes of thefollowing discussion, however, the holder or receiver assembly shall bedescribed in conjunction with a sample collection container, which maybe part of a larger fluid circuit assembly, such as the disposable bloodcollection and processing set of FIG. 1.

As shown in FIG. 1, the illustrated disposable bloodcollection/processing set 10 may include a needle such as venipunctureneedle 12, and plastic tubings 14 and 15 extending from needle 12 to acollection container such as a flexible plastic container 16. A needleprotector 17 may also be provided for retraction and storage of needle12 after use.

The blood processing set 10 may include a single blood collectioncontainer 16 or, more preferably, as shown in FIG. 1, may includeadditional containers such as 20 and 24 for separation, storage or otherprocessing of the collected blood or blood components. In accordancewith one particular, non-limiting embodiment, the disposable processingset 10 may include a sampling sub-unit 18, including sampling containeror pouch 30.

In a preferred embodiment, sampling sub-unit 18 includes a receiver orholder assembly 40 of the present invention. Receiver assembly 40 may bepre-attached to blood sampling tube 32 of sampling container or pouch30, thereby establishing flow communication between the holder assemblyand the pouch interior. Details of the blood collection and bloodsampling procedures using the above-described sets are described in U.S.Pat. Nos. 6,387,086 and 6,520,948, incorporated by reference.

In one embodiment (shown in FIG. 3), receiver assembly 40 includes anelongated hollow cylindrical housing 44, although other shapes orgeometries may also be employed. Housing 44 includes a proximal end 46and distal end 48. Housing 44 is open (and/or openable) at its proximalend 46 and is adapted for receiving therethrough a blood collection tube100, such as a Vacutainer™ vacuum collection container.

In a preferred embodiment (described in greater detail below), housing44 of holder assembly 40 includes a cover 70 for closing the openproximal end 46 of the housing 44. The distal end 48 of the housing 44is generally closed except for external access through a needlesubassembly 50 (described in greater detail below with reference to FIG.5) secured to the housing 44 at the distal end 48.

Housing 44 may be made of any suitable, plastic material that can beinjection molded and sterilized by known forms of sterilization, such asautoclaving (steam sterilization) or radiation. A preferred,autoclavable plastic material is polypropylene. Where holder assembly 40is sterilized by electron beam or gamma radiation, suitable materialsmay include polystyrene. Of course, still other materials known to thoseof skill in the art may also be used.

As shown in FIG. 3, in one embodiment, cylindrical housing 44 mayoptionally include flange 51 at or near the open proximal end 44.Sidewall 52 of housing 44 extends from flange 51 to distal end 48. Atthe distal end 48, as seen in FIG. 5, side wall 52 is interrupted byaxial through bore 54, centered within the distal end, and adapted toreceive needle subassembly 50.

As best seen in FIG. 5, axial bore 54 is defined by an interior wall 56.The housing 44 and needle subassembly 50 preferably have interlockingsurfaces for fixedly holding the needle assembly in the through bore.The interlocking surfaces may be of a variety of different arrangements.As seen in FIG. 5, wall 56 may include an interior annular shoulder orledge 59 and a radially inwardly extending rib 58 located proximallyfrom the distal end 48. The inwardly extending ledges or ribs 58 and 59are spaced apart from each other to provide an annular slot 60 in theinterior wall 56.

As further shown in FIG. 5, the diameter of distal axial bore 54 issmaller in the area proximal to second inwardly extending ledge 59, thanin the area distal to the first inwardly extending ledge 58. In theillustrated embodiment, the diameter of axial bore 54 is furthernarrowed by inwardly radially inclined wall portion 64.

As shown in FIG. 5, housing 44 may also include an inner, radiallyinward collar or ring 66. Collar 66 may be provided as a ledge orprojection extending from the interior surface of sidewall 52 into thehousing interior 53. Collar 66 provides a means for frictionallyretaining the needle protector 17 (with a used venipuncture needleretracted therein), which may be inserted into housing 44 after bloodcollection procedure is completed, as generally described in U.S. Pat.No. 6,632,201, which is incorporated herein by reference. Housing 44 mayalso include a stop surface for engaging the end of a blood samplingtube 100. In the illustrated embodiment stop surfaces are provided bythe proximal ends of ribs 68 in the distal end of the housing interior53.

Housing 44 of needle holder assembly 40 preferably includes a cover,such as cap 70 for opening and closing proximal end 46 of thecylindrical housing. Cap 70 may be separately provided or, morepreferably, may be attached to housing 44, as shown in the figures. Inone embodiment (see FIGS. 3 and 4), cap may be a “flip cap” attached tothe flange 51 by hinge 72. Hinge 72 may be formed by reducing (duringthe injection molding process) the amount of plastic material and, thus,the thickness in the section between cap 70 and flange 51, allowing foreasy bending along the hinge.

As shown in FIGS. 3 and 3A, cap 70 may also be provided with spring typeor plastic “living hinge” closure member 74. One end of closure member74 is attached to the cap 70 along thin web 76 while the other end 78 ofclosure member 74 is attached to base 79 of flange 51 along thin web 78.Closure member 74 biases the cap to either an open position or a closedposition preferentially to an intermediate position, so as to allow for“one handed” and, in fact, “one-fingered” opening and closing of cap 70.With a single flick of the thumb or finger, the technician can open orclose the cap as necessary. Closure member 74 causes cap 70 to eithersnap open or snap closed, and tends to move the cap away from anintermediate position to the open or closed position preferentially toan intermediate position. In other embodiments, cap 70 may be providedas a tethered cap (i.e., tethered to housing 44), a cap that slides overthe open proximal end, a cap that rotates between an open and closedposition, or other arrangement. A peel off seal or cover, sealedadhesively or otherwise bonded to the open end of housing 44 could alsobe used to provide a sterile barrier over the open end of housing 44until a sample is required.

As further shown in FIGS. 2 and 3, cap 70 may include a latch 80 on theinner surface 82 of cap 70. When cap 70 is in the closed position, latch80 is received within slot 84 of flange 50. Cap 70 may also includecentering ring 86 for centering cap 70 over open proximal end 46 and,thereby ensuring proper closure. Optional gap 85 between spring 74 andcap 70 allows for venting of housing interior 53 during, for example,steam sterilization.

Turning now to the needle subassembly 50, it will be appreciated thatneedle subassembly may be integrally joined to housing 44 as a one-piecearrangement or attached by adhesive or melt bonding or, more preferably,the needle subassembly may be separately formed and adapted forinterference fit to housing 44 by interlocking surfaces. Needlesubassembly 50 may include a proximal piercing end 90 and distalnon-piercing end 92. Although referred to as a needle assembly, it isabsolutely necessary that the member for a needle be used to pierce theseptum of the sample tube. A blunt cannula or the like could also beused with those sample tubes that would accommodate such. Also, whereholder assembly is a “stand-alone” type assembly intended for direct usewith a donor or patient, needle assembly 40 may include adistally-pointed needle, for example, a double-ended needle where boththe proximal and distal ends include piercing ends. Optionally, theproximal and/or distal ends of the piercing member could have thewell-known blunt cannula configuration to provide greater safety againstaccidental needle sticks, as described above.

With reference to the embodiment shown in FIG. 5, first proximalpiercing end 90 includes piercing member 91 attached to hub 94. Piercingmember 91 may be a hollow needle or cannula made of stainless steel orother rigid metal or plastic. The opposite facing distal non-piercingend 92 preferably includes a luer 96 with an internal fluid path but ablunt cannula or needle could also be used if desired. The internalfluid path of the distal end is in fluid communication with the hollowinterior of the proximal needle (piercing member) 91 via a through borein the needle hub.

As an alternative to snap attachment, the portion 93 of the body ofneedle subassembly between luer 96 and hub 94 may, optionally, bethreaded to allow attachment to housings having a threaded axial bore.However, in a preferred embodiment, needle subassembly 50 is not screwedinto housing 44, but is instead press-fit into housing 44. In onepress-fit arrangement, needle subassembly 50 may include an outwardlyextending radial ring 98 for press fit engagement with housing 44.Specifically, as needle subassembly 50 is advanced into axial bore 54,ring 98 is captured within slot 60. Further movement in the proximal ordistal directions is prevented by inwardly extending rib or ledge 58 and59, thus providing a secure attachment of needle subassembly 50 tohousing 44. These structures could be reversed, with the needle hubhaving a pair of spaced ribs defining a slot therebetween and thehousing having an annular rib for snap fit into the slot. Otherstructures, such as detents, latches and the like, could also be usedfor snap fit assembly. A secure fit is partially desired so as to avoidblood leakage.

Needle 91 is preferably enclosed within a flexible, resilient protectivesheath such as a rubber (latex) sleeve, or more preferably apolyisoprene or other non-latex sleeve 99. Sleeve 99 is located overneedle 91 and hub 94. Hub 94 may include an outwardly extending ring(not shown), to provide a tight fit between hub 94 and the distal end ofthe sleeve, and thereby hold sleeve 99 in place. Other techniques mayalso be used for attaching the sleeve to the needle hub 94 and/or thecylindrical housing 44—such as adhesive bonding, friction fit, clampingand the like. In another embodiment, sleeve 99 is loosely placed overneedle 91 and hub 94. A loose fitting or vented sleeve may be preferred(as compared to a sleeve that is stretched over the hub) in that it ispresently believed to be less susceptible to oxidation duringsterilization by electron beam or gamma sterilization. In theillustrated embodiment sleeve 99 is held in place by radially extendingwall 64.

When a vial is inserted into housing 44, the end or septum of the vialforces the needle through the proximal end of the sheath 99 and into thevial. As the vial continues to be inserted, the sheath is forceddistally to a collapsed configuration. When the vial is withdrawn, theresilient sheath 99 preferably resumes its position over the needlealthough such may not be required in sampling apparatus intended forone-time use only.

With a receiver assembly of the type described above, the technician caneasily open and close the open proximal end of the holder assembly, asnecessary. For example, once a sample has been collected (in thecollection tube), the technician can, with a simple flick of his fingeragainst the cap 70, close the housing 44. With another flick of thethumb or finger, the technician can open the housing to allow forinsertion of the next tube. Thus, it will be appreciated that the easymanipulation of cap 70 provided by the present invention allows for arapid, fluid and substantially uninterrupted sampling motion, whileprotecting the technician from accidental contact with the needlebetween sample draws, and from contact with blood residing in the holderinterior. The holder assembly can later be reopened and utilized as asecure receptacle for a used venipuncture needle/needle protector, asdescribed above. Fast and uninterrupted withdrawal is important becauseblood collected near the point of withdrawal from the donor or patientmay not contain anticoagulant and it is important to be able to collectthe sample before coagulation begins.

FIGS. 2A and 5A show alternative and preferred configurations of thecover or cap 70′, needle subassembly 50′ and housing 44′. As shown inFIG. 2A, the upper flange 51′ of the housing 44′ has a recessed edgearea R. The cover 70′ is sized to extend over and beyond the recessededge area when in the closed position, with the latch 80′ engaged to theflange at the recessed edge. The edge of the cover overlying the recessR is slightly concave. This provides a visible indicator to the userthat the user's thumb or finger can be placed in this location to raisethe cover.

FIGS. 5A and 5B show an alternative and preferred housing and needleassembly arrangement. The housing 44′ is comparable to the housing 44 ofFIG. 5 except that instead of a continuous internal rib 58, there are 4spaced-apart rib arc segments 58′, each of which extends a shortdistance around the inside of interior 56′. A small, generallyrectangular opening or window W (formed by the molding apparatus)extends through interior wall immediately above each rib segment 58′.The windows allow the molding apparatus to better form the rib segmentswithout deformation of the material when the mold opens.

The needle subassembly 50′ in this embodiment is similar to thatdescribed earlier except that it has two radial flanges or rings 98′.Referring to FIG. 5B, upper ring 98′, as seen in FIG. 5B, fits in snapengagement between the rib segments 58′ and internal shoulder or ledge59′. To prevent the escape of any blood that may leak from the inside ofhousing 44′ through the windows W, the lower ring 98′ is engaged in afluid-tight interference fit against the surface of the interior wall56′.

An alternative arrangement employing the present invention is shown inFIG. 6, which depicts a fluid circuit assembly in form of a bloodprocessing set, like that shown in FIG. 1, with the exception of thesampling sub-unit. As shown in FIG. 6, fluid circuit assembly is a bloodprocessing set principally intended for manual collection and processingof whole blood from a donor or other source. The blood processing set 10shown there includes a needle 12, tubing 14 and 15 for conveying wholeblood to a blood receiving container 16 and additional containers 20 and24 connected, via tubing, to collection container 16, for receivingblood components after a separation process has been carried out. Toprovide for sampling of the whole blood received from the donor or othersource, a sampling sub-unit 102 is provided as an integral part of thefluid circuit assembly. The sampling sub-unit 102 includes asample-receiving container 104 and a sample tube receiver or holder 106.The container receives whole blood through tubing 110 which is attachedto the blood inlet line 14 at junction 108.

The sampling sub-unit and alternative embodiments thereof are shown inFIGS. 7-11. Turning to FIG. 7, the sampling apparatus of the presentinvention, as illustrated in this embodiment, has advantages withrespect to both handling and packaging. As seen in FIGS. 7-11, thesample-receiving container is preferably, but not exclusively, aflexible container in the form of a pouch formed by peripherally sealingtogether two facing flexible plastic sheets 112 and 114. The sheets,which may be of polyvinylchloride or other suitable material, eitherwith or without plasticizer, that can withstand gamma or E-beamirradiation sterilization or autoclave sterilization, are peripherallysealed together along a peripheral edge 116 to define a generally closedinternal chamber for receiving blood or other biological fluid throughtubing 108. The container 104 may be of any suitable shape, but in thepreferred embodiment, the container walls are shaped to direct theincoming blood (or other fluid if used in a non-blood collection fluidcircuit) to a selected location in the interior chamber. In theembodiment shown in FIG. 7, the container is adapted for holding in agenerally vertical position, as shown in FIG. 7, and fluid is directedinto the lowermost region of the container by the inclined peripheraledges in the lower portion of the container. For purposes of referenceand description in discussing its vertical position, the container isshown as having an imaginary vertical axis X.

To assist and accommodate the vertical disposition of the container 104,inlet tubing 108, as illustrated in FIG. 7, extends through theperipheral edge 116 in a direction which is at an acute angle A withrespect to the imaginary vertical axis of the container.

To remove samples from the container, the sampling sub-unit 102 includesthe sample tube holder or receiver 106 of the present invention, whichis carried by a wall of the container and preferably directly attachedto a wall of the container. The sample tube receiver or holder 106 isessentially identical to that previously described in FIGS. 2-5, andincludes a generally cylindrical housing 44 with proximal and distalends 46 and 48, and having a piercing member such as a needle 99 mountedtherewithin for cooperation with a sample collection container or vial100.

In the embodiment shown in FIG. 7, the distal end member 46 of thereceiver assembly is attached, such as by ultrasonic welding, bonding orthe like to a mounting member 120 that has a peripheral flange 122 forattachment to the flexible plastic sheet of the container. As best seenin FIG. 11, the mounting member 120 includes an interior passageway 124that allows the sample tube receiver to communicate directly with asample exit opening 126 located in the wall of the container. The exitopening 126 from the container is preferably located in the area wherefluid collects and where is fluid is directed to collect by the walls ofthe container. In the embodiment shown in FIGS. 7 and 11, this islowermost region of the container when the container is in the verticaldisposition. To direct the blood to the lowermost region, the lowerperipheral edges of the container, as seen in FIG. 7, are inclined tochannel or funnel the fluid into the lowermost region. This arrangementbetter assures that substantially the entire sample collected within thecontainer may be withdrawn if desired and has other advantages as well.

The sampling apparatus shown in FIG. 7 has the additional benefit of acompact, lay-flat configuration for packaging. As can be seen in atleast FIGS. 7, 8 and 9, the sample tube holder or receiver 106 does notextend substantially beyond the peripheral edge of the container towhich it is mounted, and substantially overlies the container. In otherwords, the receiver 106 is entirely or substantially within the“footprint” of the container. This aspect of the combined container andreceiver cooperates with the angular direction of the tubing 108 toprovide a convenient lay-flat configuration of the container and sampletube receiver, with the inlet tubing 108 coiled around it. For example,as seen in FIG. 11, the sample tube receiver and container provide a lowprofile packaging arrangement between upper and lower walls 128 and 130of an outer package, and the coiled tubing fits easily with the lowprofile package, as illustrated in FIG. 11A.

Additional embodiments of the present invention, with differingconfigurations of the sample receiving container are shown in FIGS.8-10. As shown in FIG. 8, the sample receiving container 132 is shapedsimilarly to that of FIG. 7, with the exception that the containerincludes a laterally extending region 134 at which the inlet tube 136 isattached in a generally vertical direction. Thus, the interior chamberof the container also includes, in part, a laterally extending region,into which the inlet tube 136 communicates. The sample tube receiver orholder 106 employed in FIG. 8 is essentially identical to that shown inFIG. 7, and is attached, by a mounting member 120, to a wall of thecontainer so that it communicates with the interior chamber in thelowermost region of the container where the blood is directed.

Another embodiment of the sampling apparatus of the present invention isshown in FIG. 9. The sample container 138 of FIG. 9 is likewise made byperipherally sealing together a pair of flexible plastic sheets. In thisembodiment as in the other embodiments discussed, the container couldhave one or more rigid walls, and be made of injection molded plastic,if it were so desired, without departing from broader aspects of thepresent invention.

The container 138 in FIG. 9 has a generally large central region 139 anda pair of opposed lateral regions 141 into which fluid flow tubing 140and 142 communicate. In this embodiment, for example, tubing 140 couldconnect the container directly to the blood flow inlet line, and tubing142 could be used for withdrawing blood from the container so that thesampling apparatus is not at the end of a fluid communication line, butis in-line in a fluid flow passageway that leads to another part of thefluid circuit.

Also intended for holding in a vertical disposition, the container 138in FIG. 9 has a generally arcuate or upwardly concave lower peripheraledge, so that blood is directed into the lowermost region. The containerwall includes an exit opening in the lowermost region to permit bloodflow from the container to a sample tube located in the receiver 106.The receiver is mounted, via mounting member 120, in the same manner asdescribed above with respect to FIGS. 7 and 11.

FIG. 10 shows another sampling apparatus embodying certain aspects ofthe present invention, which is identical to FIG. 9, except that thesample tube receiver is mounted in one of the laterally offset extendingregions of the container, and the container does not have an outlettube.

FIGS. 12-13 show how the apparatus of the present invention may beemployed in taking a sample from a fluid circuit assembly. Havingcollected a fluid sample through tubing 108 into the container 104, thecontainer and receiver are held in a generally vertical position, withthe proximal end of the receiver facing upwardly, and the cover or capof the container is opened. As explained earlier, the living hingearrangement moves the cap to an open position with a simple flick of thethumb to raise the cap. The blood collection vial or tube 100 is theninserted downwardly into the receiver, as shown in FIG. 13. The bloodcollection tube includes a septum of latex or other suitable material atthe bottom of the tube that is pierced by the needle 99 located withinthe cylindrical housing of the receiver. The interior of the bloodcollection tube typically is a vacuum, which tends to draw contents fromthe sample outlet in the lowermost region of the container upwardlythrough the mounting member and needle and into the collection tube.This procedure, which requires minimal manipulation of the container andblood sample and employs a vertical insertion of the sample tube, hasthe further advantage of reducing hemolysis of the blood or bloodcomponent. Repeated samples can be taken simultaneously or periodicallyas usage requires. When the sample has been taken, the cap on the tubereceiver is closed to protect the interior needle from accidentalengagement by the user.

As described earlier, in addition to possible stand-alone applications,the present invention may be used in both manual and automated fluidcircuit assemblies. FIGS. 1 and 6 illustrate typical manual fluidcircuit assemblies for blood and blood component collection. FIG. 14illustrates a fluid circuit assembly specifically intended for automatedcollection and processing and employing the sample apparatus of thepresent invention. Except for the sample apparatus of the presentinvention, the fluid circuit assembly and automated collection deviceshown in FIG. 14 are as described in detail in U.S. Pat. No. 6,325,775,which is incorporated by reference herein.

The fluid circuit, generally at 144, shown in FIG. 14 is intended foruse with a portable, suitcase-size processing device 146. Withoutrepeating all of the disclosure set forth in the above-identifiedpatent, which is incorporated by reference, the disposable fluid circuitassembly shown in FIG. 14 includes a fluid circuit control module 148which is adapted for mounting onto the device 146, and which hasassociated controllers for controlling the direction and flow throughthe fluid circuit. The fluid circuit assembly may also include aseparation device, generally at 150, through which anticoagulated wholeblood flows for separation into one or more blood components, such asred cells, platelets or plasma. The fluid circuit assembly may alsoinclude miscellaneous containers 152 for receiving blood or bloodcomponents or for containing anitcoagulant, saline, or other liquidsrequired during the blood processing.

In accordance with the present invention, blood sampling apparatus orsub-unit 102 is attached to the fluid circuit assembly at a Y-site orV-site junction 154 in the line leading from the donor access needle,preferably before anticoagulant is added to the whole blood at junction155, although it may be attached at any other location in the fluidcircuit where there is a need or desire to sample the fluid at thatlocation. In all other respects, the sampling apparatus 102 is identicalto that described earlier in connection with FIGS. 7 and 11-13.

Turning now to a description of the needle 99 employed in the samplereceiver, it should first be noted that the needle may be used torepeatedly puncture the rubber or latex septum of a sample tube, and itis desirable that the needle not unduly damage the septum or generateparticulate matter.

FIGS. 15-19 show prior needle tip designs that have been employed invarious medical applications. FIGS. 15-16 show the sharpened end of astainless steel needle 160, employing a straight bevel facet to form theneedle tip. FIG. 15 is a cross-sectional view of such a needle, andshows a straight or plain beveled surface 162. FIG. 16 shows the sameneedle and the elliptical facet surface 162 from a top view.

FIGS. 17-19 illustrate another prior needle 164. The sharpened tip ofneedle 164 has a flat or straight primary bevel grind surface 166 in aproximal region of the needle tip, and outwardly angled (or downwardlydiverging) secondary bevel facets 168 leading from the flat bevel to thedistal most end of the needle tip. The primary bevel is subjected tomicrosandblasting, a technique known in the field, which erodes theedges of the primary bevel to make the heel of the needle opening morerounded.

FIGS. 20-23 show the tip configuration of a needle 170 as preferablyused in the fluid sampling apparatus of the present invention. Theneedle tip there includes a generally flat primary needle grind togenerate facet 172 in a proximal region of the needle tip. A pair ofinwardly angled (or downwardly converging) secondary side bevel grindsurfaces or facets 174 are next formed sequentially at the distal mostend of the needle tip. These secondary facets may be formed by rotatingthe needle shaft in one direction for a selected angle greater than 90°and less than 180°, grinding one secondary facet and then rotating theneedle back to the start position and then in the other direction at thesame angular displacement, where the other secondary facet is ground.The two secondary facets preferably extend not more than about 30% ofthe length of the primary bevel. The intersection of the internalsurface of the hollow needle with the proximal portion of the primarybevel (the heel) can be a very sharp edge or blade that is responsiblefor coring of the septum or other material pierced by the needle. Toreduce the potential for coring, the proximal portion of the primarybevel, at least in the area of the heel, is preferably microsandblastedto smooth the sharp edges and reduce the potential for coring. The sidebevel facets 174 converge at the tip to form the distal most tip 176 ofthe needle at an interior location spaced a distance D from the sidesurface of the needle shaft.

Tests of the needle 170 show substantially improved results relative toseptum destruction or particle generation. FIG. 26 shows a typicalcollection tube septum 180 repeatedly punctured or pierced six timeswith the needle 170. The puncture area is visible, but limited andconfined to generally one location. FIG. 25 shows such a septumrepeatedly pierced six times with the prior art needle of FIGS. 15-16.This needle tends to enter the septum at different locations with eachpuncture, and the tearing and destruction of the septum is more severeand is not localized.

FIG. 24 shows an alternative needle 180 which may also provide forimproved septum piercing in which the needle tip is generally plain andclosed, except for a lateral rectangular aperture 182 formed in the sideof the needle wall for fluid communication after the septum has beenpierced by the closed point of the needle shaft.

Although the present invention has been described in terms of theillustrated embodiments, the intended scope of the invention is as setforth in the appended claims and the illustrated embodiments in thisdescription are intended as an illustration and not intended as alimitation to the subject matter set forth in the claims.

1. Sampling apparatus comprising a sample container including at leastone wall defining a fluid-receiving interior chamber in which thecontainer is adapted to be held in a selected position for withdrawing afluid sample, in which position the container has a generally verticalaxis, the apparatus further comprising a fluid inlet for receiving fluidinto the chamber and flexible tubing communicating with the fluid inlet,the tubing being disposed at an acute angle to the vertical axis and asample device receiver carried by the container wall and in fluidcommunication with the chamber, the receiver being adapted to receive asampling device for withdrawing a fluid sample from the chamber.
 2. Theapparatus of claim 1 in which the tubing extends in a coil configurationaround the container to provide a compact configuration for packaging.3. Sampling apparatus comprising: a sample container including at leastone wall defining a fluid-receiving interior chamber and wherein thecontainer has an outer peripheral edge, wherein said container isadapted to be held in a selected position for withdrawing a fluidsample, said container including walls shaped to form a lowermost pointin the interior chamber and to direct fluid in the interior chamber tothe lowest point in the chamber when the container is in the selectedposition, the container further including a fluid inlet for receivingfluid into the chamber; and a sample tube receiver carried by thecontainer wall wherein the receiver is situated such that the receiveris located substantially within the outer peripheral edge and no part ofthe receiver extends substantially beyond the peripheral edge, thereceiver being adapted to removably receive therethrough a sampling tubefor withdrawing a fluid sample from the chamber, the receivercommunicating with the interior chamber in the vicinity of the lowermostpoint so that substantially all of the fluid within the interior chambermay be withdrawn.
 4. The apparatus of claim 3 in which the sample tubereceiver is disposed to receive a sampling tube in a vertical directionwhen the container is in the selected position.
 5. Sampling apparatuscomprising a sample container comprising facing flexible plastic sheetsperipherally sealed together to define an interior chamber, wherein thecontainer has an outer peripheral edge, the container further includinga fluid inlet for receiving fluid into the chamber, the container beingadapted for holding in a generally vertical disposition and theperipheral edges is inclined to direct fluid into a lowermost region ofthe chamber when the container is in the vertical disposition, and asample tube receiver carried by the container wall wherein the receiveris situated such that the receiver is located substantially within theouter peripheral edge and no part of the receiver extends substantiallybeyond the peripheral edge, the receiver being adapted to removablyreceive therethrough a sampling tube for withdrawing a fluid sample fromthe chamber.
 6. Sampling apparatus comprising a sample containerincluding at least one wall defining a fluid-receiving interior chamberand wherein the container has an outer peripheral edge, the containerfurther including a fluid inlet for receiving fluid into the chamber anda sample tube receiver carried by the container wall wherein thereceiver is situated such that the receiver is located substantiallywithin the outer peripheral edge and no part of the receiver extendssubstantially beyond the peripheral edge, the receiver being adapted toremovably receive therethrough a sampling tube for withdrawing a fluidsample from the chamber, the receiver further comprising a needleassembly including a piercing end and a non-piercing end; a generallycylindrical housing including a distal end engageable with the needleassembly, a proximal end adapted to receive a blood collection tube, anda sidewall extending between the proximal and distal ends; and a covermovably associated with the proximal end of the cylindrical body andmovable between a closed position covering the proximal end and an openposition opening the proximal end.
 7. The apparatus of claim 6, whereinthe distal end of the housing further comprises a through-bore definedby an interior wall.
 8. The apparatus of claim 7 in which the housingand needle assembly have interlocking surfaces for fixedly holding theneedle assembly in the through bore.
 9. The apparatus of claim 8 whereinthe needle assembly includes radially extending rib; and the interiorwall of the through bore defines a slot for receiving and securing saidradial rib of the needle assembly.
 10. The apparatus of claim 8, whereinthe slot in the interior wall of the through bore is defined between afirst inwardly extending radial ledge and a second inwardly extendingradial ledge axially spaced from the first inwardly extending ledge. 11.The apparatus of claim 6, further comprising a sleeve disposed over thepiercing end of the needle assembly.
 12. The apparatus of claim 11 inwhich the interior wall of the through bore further includes an inwardlyprojecting member engageable with the sleeve.
 13. The apparatus of claim6, wherein said cover is attached to said housing by a hinge.
 14. Theapparatus of claim 13, further comprising a closure member that has afirst end attached to the cover and a second end attached to thehousing, the closure member being disposed to hold the cover in eitherthe open or closed position and to move the cover preferentially from anintermediate position to the open or closed position.
 15. A disposablefluid circuit assembly for processing, storing, separating or treating abiological fluid such as blood or blood components, an inlet forreceiving a biological fluid into the fluid circuit assembly; one ormore flow paths for conducting the biological fluid or componentsthereof between selected locations within the fluid circuit; a samplecontainer including at least one wall defining a fluid-receivinginterior chamber and wherein the container has an outer peripheral edge,the container further including a fluid inlet for receiving biologicalfluid or component into the chamber; and a sample device receivercarried by the container wall and in fluid communication with thechamber wherein the receiver is situated such that the receiver islocated substantially within the outer peripheral edge and no part ofthe receiver extends substantially beyond the peripheral edge, thereceiver being adapted to receive a sampling device for withdrawing afluid sample from the chamber.
 16. The fluid circuit assembly of claim15 in which the container is adapted to collect fluid at a selected areain the interior chamber and the sample device receiver communicates withthe chamber at the selected area.
 17. The fluid circuit assembly ofclaim 15 in which the tubing extends in a coil configuration around thecontainer to provide a compact configuration for packaging.
 18. Thefluid circuit assembly of claim 15 in which the container comprisesfacing flexible plastic sheets peripherally sealed together to definethe interior chamber, the receiver overlying one of the sheets andcommunicating through such sheet with the interior chamber.
 19. Thefluid circuit assembly of claim 15 in which the container compriseswalls shaped to direct fluid to the selected area in the interiorchamber.
 20. The fluid circuit assembly of claim 15 in which thecontainer is adapted for holding in a generally vertical disposition andthe container includes walls shaped to direct fluid in the interiorchamber to the lowest point in the chamber when the container is in thevertical disposition, the receiver communicating with the interiorchamber in the vicinity of the lowest point so that substantially all ofthe fluid within the interior chamber may be withdrawn.
 21. The fluidcircuit assembly of claim 20 in which the sample device receiver isdisposed to receive a sampling device in a vertical direction when thecontainer is in the vertical disposition.
 22. The fluid circuit assemblyof claim 15 in which the container comprises facing flexible plasticsheets peripherally sealed together to define the interior chamber, thecontainer being adapted for holding in a generally vertical dispositionand the peripheral edges are inclined to direct fluid into a lowermostregion of the chamber when the container is in the vertical disposition.23. The fluid circuit assembly of claim 22 in which the receivercommunicates with the lowermost region of the chamber.
 24. The fluidcircuit assembly of claim 15 in which the receiver comprises a tubularmember, one end of the tubular member being open or openable forreceiving a sample tube and the other end communicating with thechamber, the tubular member including a hollow piercing member locatedin the interior of the tubular member and in fluid communication withthe interior chamber and disposed to enter a sample tube inserted intothe tubular member.
 25. The fluid circuit assembly of claim 24 in whichthe sample container is adapted to be held in a vertical orientation andthe tubular member is disposed to extend in a generally verticaldirection, with the one end facing upwardly when the sample container isin a vertical orientation so as to allow a sample tube to be insertedvertically downwardly into the tubular member.
 26. The fluid circuitassembly of claim 15 in which the receiver comprises: a needle assemblyincluding a piercing end and a non-piercing end; a generally cylindricalhousing including a distal end engageable with the needle assembly, aproximal end adapted to receive a blood collection tube, and a sidewallextending between the proximal and distal ends; and a cover movablyassociated with the proximal end of the cylindrical body and movablebetween a closed position covering the proximal end and an open positionopening the proximal end.
 27. The fluid circuit assembly of claim 26,wherein the distal end of the housing further comprises a through boredefined by an interior wall.
 28. The fluid circuit assembly of claim 27wherein the needle assembly and housing have interlocking surfaces forfixedly positioning the needle assembly in the through bore.
 29. Thefluid circuit assembly of claim 28, wherein a slot is defined in theinterior wall of the through bore and the needle assembly includes anannular rib for interfitting in the slot.
 30. The fluid circuit assemblyof claim 27, wherein the needle assembly further includes a sleevedisposed over the piercing end of the needle assembly.
 31. The fluidcircuit assembly of claim 26, wherein said cover is attached to saidhousing by a hinge.
 32. The fluid circuit assembly of claim 31, furthercomprising a closure member with a first end attached to the cover and asecond end attached to the housing, the closure member being disposed tohold the cover in either the open or close position and to move thecover preferentially from an intermediate position to the open or closedposition.
 33. The disposable fluid circuit assembly of claim 15 whereinsaid sample container comprises a pair of flexible facing plastic sheetsperipherally sealed together along a peripheral edge to define aninterior chamber and adapted for holding in a generally verticaldisposition, a blood component inlet tube communicating between thechamber and one or more flow paths or selected locations within thefluid circuit, the peripheral edge being inclined to direct bloodcomponent in the chamber to a lowermost region of the chamber when inthe vertical position and a blood component sample exit opening locatedin one of the sheets in the lowermost region.
 34. The fluid circuitassembly of claim 33 wherein the sample container includes a main pouchregion and at least one laterally offset pouch region and the bloodcomponent inlet tube is attached to the pouch at the laterally offsetregion.
 35. The fluid circuit assembly of claim 33 further includes ablood component removal tube communicating with the chamber.
 36. Thefluid circuit assembly of claim 35 wherein the sample container includesa main pouch area and opposed laterally offset pouch regions, the bloodcomponent inlet tube being attached to the pouch at one of the laterallyoffset regions and the blood component removal tube being attached atthe other laterally offset region.
 37. A disposable fluid circuitassembly for processing, storing, separating or treating a biologicalfluid such as blood or blood components, an inlet for receiving abiological fluid into the fluid circuit assembly; one or more flow pathsfor conducting the biological fluid or components thereof betweenselected locations within the fluid circuit; a sample containerincluding at least one wall defining a fluid-receiving interior chamberand including a fluid inlet for receiving biological fluid or componentinto the chamber in which the container has a generally vertical axisand in which the assembly further comprises flexible tubingcommunicating with the fluid inlet, the tubing being disposed at anacute angle to the vertical axis; and a sample device receiver carriedby the container wall and in fluid communication with the chamber, thereceiver being adapted to receive a sampling device for withdrawing afluid sample from the chamber.
 38. The fluid circuit assembly of claim37 wherein the inlet is adapted for withdrawing whole blood from a humanand the fluid circuit comprises a flow path for conducting the wholeblood or a component thereof to a desired location within the fluidcircuit, the fluid inlet to the interior chamber communicating with theblood or blood component flow path for receiving a sample of the bloodor blood component into the chamber.
 39. A disposable fluid circuitassembly for processing, storing, separating or treating a biologicalfluid such as blood or blood components, an inlet for receiving abiological fluid into the fluid circuit assembly; one or more flow pathsfor conducting the biological fluid or components thereof betweenselected locations within the fluid circuit; a sample containerincluding at least one wall defining a fluid-receiving interior chamberand including a fluid inlet for receiving biological fluid or componentinto the chamber and in which the container includes a main chamberregion and at least one laterally offset chamber region and the fluidinlet to the chamber is located in the laterally offset region and; asample device receiver carried by the container wall and in fluidcommunication with the chamber, the receiver being adapted to receive asampling device for withdrawing a fluid sample from the chamber.
 40. Thefluid circuit assembly of claim 39 in which the container includesopposed laterally offset chamber regions.
 41. The fluid circuit assemblyof claim 40 further comprising a fluid outlet located in laterallyoffset chamber region.
 42. A method for taking a sample of biologicalfluid comprising: providing a sampling apparatus comprising a samplecontainer including at least one wall defining a fluid-receivinginterior chamber and including a fluid inlet for receiving fluid intothe chamber; a sample device receiver carried by the container wall andin fluid communication with the chamber, the receiver being adapted toreceive a sampling device for withdrawing a fluid sample from thechamber wherein the sample receiver further comprises a tubular memberwith a proximal end and a distal end and a cover removably covering theproximal end and the method includes opening the cover; holding thesample device receiver and sample containers such that the receiver isdisposed to receive the sample device into operative position for samplewithdrawal in a generally vertical direction; inserting the sampledevice into the receiver in a generally vertically downward direction,the sample receiver communicating with a lowermost region of the samplecontainer as held so as to withdraw a sample generally vertically intothe sample device; and withdrawing the sample device after a sample iswithdrawn and closing the cover over the proximal end.
 43. Samplingapparatus comprising a sample container including at least one walldefining a fluid-receiving interior chamber and including a fluid inletfor receiving fluid into the chamber and wherein said sample containercomprises a pair of flexible facing plastic sheets peripherally sealedtogether along a peripheral edge to define an interior chamber, thecontainer being adapted for holding in a generally vertical disposition,a blood component inlet tube communicating with the chamber, theperipheral edge being inclined to direct blood component in the chamberto a lowermost region of the chamber when in the vertical position and ablood component sample exit opening located in one of the sheets in thelowermost region, and a sample tube receiver carried by the containerwall and in fluid communication with the chamber, the receiver beingadapted to removably receive therethrough a sampling tube forwithdrawing a fluid sample from the chamber.
 44. The sampling apparatusof claim 43 wherein the sample container includes a main pouch regionand at least one laterally offset pouch region and the blood componentinlet tube is attached to the pouch at the laterally offset region. 45.The sampling apparatus of claim 43 further includes a blood componentremoval tube communicating with the chamber.
 46. The sampling apparatusof claim 45 wherein the sample container includes a main pouch area andopposed laterally offset pouch regions, the blood component inlet tubebeing attached to the pouch at one of the laterally offset regions andthe blood component removal tube being attached at the other laterallyoffset region.